a phase ii study to treat subjects with advanced renal cell carcinoma

Conditions: Advanced Renal Cell Carcinoma

Summary: the purpose of this study is to evaluate the effectiveness and safety of amg 102 in patients with advanced renal cancer.


Eligibility criteria:
inclusion criteria: * documented histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (ct or mri) or ≥ 10 mm by spiral ct scan * no more than 3 relapses (or prior systemic treatments) * unable to receive or failed prior therapy with vascular endothelial growth factor (vegf) binding agents or vegf receptor tyrosine kinase inhibitors or other multi-kinase inhibitors * tissue blocks or tissue sections from initial or upon diagnosis of advanced metastatic disease are available for submission to the central laboratory within approximately 4 weeks after enrollment or approval is granted by the sponsor (upon receipt of justification why the sample is not available) * age ≥ 18 years * ecog performance status of 0-2 * hemoglobin concentration ≥ 9 g/dl * absolute neutrophil count ≥ 1.5 x 10(9th)/l * corrected serum calcium ≤ 10 mg/dl * either serum creatinine \ 40 ml/min * alanine aminotransferase ≤ 2.5 times upper limit of normal or \< 5.0 x uln if the subject has documented liver metastasis or primary hepatic neoplasm * serum total bilirubin ≤ 2.5 times upper limit of normal * before any study-specific procedure, the appropriate written informed consent must be obtained exclusion criteria: * active brain metastases; brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral ct or mri scan 2 months following surgery and/or radiation therapy * concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study * documented history of human immunodeficiency virus infection * documented history of viral chronic hepatitis * received biologic, small molecule, immunotherapy, chemotherapy, radiotherapy or other agents to treat renal cancer within 28 days before enrollment * treated previously with c-met or hgf targeted therapy * concurrent or prior (within 7 days before enrollment) anticoagulation therapy, except: * use of low-dose warfarin (\< 2 mg/day) for prophylaxis against central venous catheter thrombosis or * use of low molecular weight heparins (lmwh, e.g., enoxaparin sodium \[lovenox\] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed * concurrent use of hormones or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (eg, insulin for diabetes); except for non-cancer reasons * concurrent palliative or therapeutic radiation therapy * currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapy, or subject is receiving other investigational agent(s) * active infection requiring treatment within 1 week before enrollment * undergone major surgery within 4 weeks before enrollment or recovering from prior surgery * past or current history of another neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative treatment administered for the last 3 years * known allergy or sensitivity to any of the excipients in the investigational product to be administered * pregnant or is breast feeding * not consenting to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product: * female subjects who are not post-menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this exclusion * previously treated with amg 102 * previously enrolled into this study * will not be available for follow-up assessments * has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures * unable to begin protocol specified treatment within 3 days after enrollment

Keywords: renal cancer kidney cancer